NDC | 36800-569-01 |
Set ID | 55762d52-a35b-4087-b133-a9f446f64f7f |
Category | HUMAN OTC DRUG LABEL |
Packager | TopCo Associates LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- runny nose and sneezing (SINUS NIGHT ONLY)
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (SINUS DAY ONLY)
- temporarily relieves:
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert
acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin (SINUS NIGHT ONLY)
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma (SINUS NIGHT ONLY)
- a breathing problem such as emphysema or chronic bronchitis (SINUS NIGHT ONLY)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS DAY ONLY)
- cough that occurs with too much phlegm (mucus) (SINUS DAY ONLY)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (SINUS NIGHT ONLY)
When using this product
- do not use more than directed
- excitability may occur, especially in children (SINUS NIGHT ONLY)
- marked drowsiness may occur (SINUS NIGHT ONLY)
- alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS NIGHT ONLY)
- avoid alcoholic drinks (SINUS NIGHT ONLY)
- be careful when driving a motor vehicle or operating machinery (SINUS NIGHT ONLY)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or persistent headache
These could be signs of a serious condition.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- do not take more than directed (see Overdose warning)
- do not take Sinus Day and Sinus Night caplets at the same time
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
- Other information
-
Inactive ingredients
SINUS DAY
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
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PRINCIPAL DISPLAY PANEL
NDC 36800-569-01
TopCare® Health
For Ages 12+
Compare to Mucinex® Sinus-Max™ Day & Night Active Ingredients*
Maximum Strength†
Sinus Relief Day & Night
Daytime
Pain Reliever – Acetaminophen
Expectorant – Guaifenesin
Nasal Decongestant – Phenylephrine HCl
Day Caplet Relieves:
Sinus Pressure
Headache & Congestion
Thins & Loosens Mucus
Nighttime
Pain Reliever – Acetaminophen
Antihistamine – Diphenhydramine HCl
Nasal Decongestant – Phenylephrine HCl
Night Caplet Relieves:
Nasal Congestion
Sinus Pressure & Pain
Runny Nose & Sneezing
Our Pharmacists Recommend
10 Day Caplets
10 Night Caplets
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INGREDIENTS AND APPEARANCE
SINUS RELIEF DAY AND NIGHT
acetaminophen, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-569 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-569-01 1 in 1 CARTON; Type 0: Not a Combination Product 06/30/2017 08/31/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 10 Part 2 1 BLISTER PACK 10 Part 1 of 2 ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape OVAL Size 19mm Flavor Imprint Code AAA;1166 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 Part 2 of 2 ACETAMINOPHEN, DIPHENHYDRAMINE HYROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength COPOVIDONE (UNII: D9C330MD8B) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color blue Score no score Shape OVAL (capsule-shaped) Size 17mm Flavor Imprint Code AAA;1116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2017 08/31/2023 Labeler - TopCo Associates LLC (006935977)